4.1 Are all product receipts performed according to written procedures?

4.2 Is product reception recorded/documented according to a written procedure?

4.3 Are there appropriate intake control procedures in place with conformity inspection, including the seals?

4.4 Are there appropriate written procedures for cleaning and maintenance of tanks/silos?

4.5 Are there written procedures and documentation for loading of products?

4.6 Are there written procedures and documentation for unloading of products?

4.7 Are there written procedures to prevent contamination in the case that a container has to be opened?

4.8 In the case that a container has to be opened, is there a quality re-certification and release procedure?

4.9 Is there a procedure for re-sealing containers after opening?

4.10 Are there written procedures for storage and warehousing of products?

4.11 Does the procedure for storage of packaged products consider the risk of incompatibilities between products?

4.12 Is the product received in bulk checked and/or tested for quality and identification at the receiving site?

4.13 Is each product lot released and re-certified each time it is mixed with another lot?

4.14 Are materials stored in compliance with safety requirements?

4.15 Are containers stored in dedicated areas with adequate separation from other products in order to prevent errors?

4.16 Are the racking systems in good condition and protected from vehicle collision?

4.17 Are containers of sensitive products stored under appropriate storage conditions that are adequately monitored?

4.18 Are containers stored protected from adverse weather conditions?

4.19 Are receipt and dispatch bays equipped with means to protect materials from weather?

4.20 Are rejected and recalled materials stored in a defined segregated area?

4.21 Are materials in segregated areas controlled with appropriate systems (e.g. physical or computerized)?

4.22 Are segregated materials appropriately labelled?

4.23 Are specific storage conditions maintained, monitored and controlled where necessary?

4.24 Are storage requirements for dangerous goods met on site and during transportation?

4.25 Is there a system in place to ensure that equipment for bulk storage is designed according to product requirements?

4.26 Is the storage tank equipped with a monitored nitrogen blanketing system or a drying equipment, if necessary, to protect the product against oxidation and / or moisture?

4.27 Is the quality of the blanketing gas, if used, compatible with the product?

4.28 Is it ensured that the storage temperature is always kept within a defined range and controlled, if necessary for product quality or stability?

4.29 Is adequate spill clean-up equipment available and are procedures in place for containing/collecting any spillage?

4.30 Can spills be adequately contained?

4.31 Are waste materials awaiting disposal stored safely and properly?

4.32 Does the company apply FIFO (First In First Out) or EEFO (Earliest Expiry First Out) principles in the warehouse?

4.33 Are containers stored subject to a shelf life control system?

4.34 Is there a separate storage area provided for pharmaceutical starting materials?

4.35 Is there a written cleaning program in place?

4.36 Are there records for cleaning activities available?